Cleared Traditional

PAGALINOR 4 , ALLOY NO. 5440

K993506 · Metalor Dental USA Corp. · Dental
Dec 1999
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K993506 is an FDA 510(k) clearance for the PAGALINOR 4 , ALLOY NO. 5440, a Alloy, Other Noble Metal (Class II — Special Controls, product code EJS), submitted by Metalor Dental USA Corp. (North Attleborough, US). The FDA issued a Cleared decision on December 8, 1999, 54 days after receiving the submission on October 15, 1999. This device falls under the Dental review panel. Regulated under 21 CFR 872.3060.

Submission Details

510(k) Number K993506 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 1999
Decision Date December 08, 1999
Days to Decision 54 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EJS — Alloy, Other Noble Metal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3060